Research record retention requirements, including the length of time files must be retained, are mandated by FDA regulations, ICH guidelines, non-U.S. regulatory agencies, and the sponsoring company’s SOPs. After a study closes, retention requirements are minimally two years but often exceed 15-30 years. The common requirements for storage of research patient case histories and essential documents (TMF) include:
- Continual secure protection with limited access to patient and trial data
- Complete, readily available files that are accessible for inspection
- Assurances of safety from issues such as fires, water damage, pests, etc.
- Ongoing documentation of archive locations; sites to notify the sponsor/CRO if the location changes
For bulky paper records, it can be difficult to find enough, safe, secure space for archiving within a site’s facility. Alternatively, the study files can be moved to an outside storage facility. However, it can be expensive and inconvenient to purchase secure storage and move the study files to an outside facility with the capacity needed to compliantly accommodate the documents. If an audit is needed, the documents have to be brought back to the research site, incurring additional fees and transportation costs. The documents then need to be organized in readiness for the audit.
With the increased use of secure portals and electronic data capture, the need for paper records has decreased and may eventually disappear. However, many studies still use paper CRFs and regulatory documents or a mix of paper and electronic data, necessitating costly, inconvenient archiving.
In time, clinical study files may become fully digital. Until this occurs, solutions exist to provide complete, compliant digital study archives, saving space and long-term costs. There’s also a greater chance that a digitally archived study could be more conveniently stored at the site. If an audit is required, digital records are already organized, complete, and ready for review at any time.
Imperial offers a dedicated, secure, and highly efficient solution for study document archiving.
- Study data and associated documents are directly obtained from various EDC vendors or customer-supplied media.
- When the data is ready for archiving, a permanent electronic record of the subject files, completion guidelines, associated documents, as well as a composite trial master file are created and delivered.
- The permanent archives are promptly delivered to trial sites or study managers located anywhere in the world.
Complete, secure, safe, archival of study documents is required and a study must remain fully available for regulatory review, upon request. Find a painless, compliant digital archive solution for your study.
Contact Imperial to hear more about our solution by emailing email@example.com or calling 800.777.2591.